RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)

Secondary

Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)

Evaluate the safety profiles of this regimen in these patients. (Phase I)

Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)

Determine the overall survival of patients treated with this regimen. (Phase II)

Determine the overall response in patients treated with this regimen. (Phase II)

Evaluate the safety and toxicity of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter study.

Patients receive paclitaxel-loaded polymeric micelle and carboplatin.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced ovarian cancer

Measurable disease by RECIST criteria

No prior or concurrent CNS metastasis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2

Life expectancy > 6 months

Clinically acceptable blood, kidney, and spleen function

Not pregnant or nursing

Fertile patients must use effective contraception

No preexisting sensory or motor neuropathy ≥ grade 1

No other malignancies within the past 5 years

PRIOR CONCURRENT THERAPY:

No prior chemotherapy for ovarian cancer

No prior immunotherapy or hormonal therapy for ovarian cancer

No prior radiotherapy to the pelvis or abdominal cavity

More than 2 weeks since prior major surgery other than debulking surgery

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886717